Hillstream BioPharma, Inc. is a biotechnology company developing therapeutic candidates targeting drug resistant and devastating cancers using ferroptosis, an emerging new anti-cancer mechanism resulting in iron mediated cell death, and immuno-oncology targeted novel biologics. The Company’s most advanced candidate, HSB-1216, expected to enter clinical trials in 2023, targets ferroptosis, an emerging new anti-cancer mechanism resulting in iron mediated cell death (IMCD) of drug resistant cancers. The Company’s emerging immuno-oncology pipeline is led by the HSB-1940 Quatrabody™, an anti-PD-1 novel biologic coated onto Quatramers, expected to enter the clinic in 2024. Hillstream’s Quatramer™ proprietary tumor targeting platform extends duration of action and minimizes off-target toxicity for biologics, mRNA, peptides, small molecules and other modalities in the tumor microenvironment. Quatrabody conjugates novel biologics developed against undruggable epitopes of validated immuno-oncology targets, including PD-1, HER2, PDL-1 and TROP2 with greater binding affinity than approved therapies.
Mr. Milby was the former Chief Executive Officer and Member of the Board of Directors at CorMedix, a publicly traded biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of inflammatory and infectious diseases. A seasoned executive who led the increase in market capitalization from $3M to a peak of $350M of Cormedix while improving the company’s financial position with capital raises from equity markets. He oversaw efforts to gain CE Market approval of Neutrolin® in the European Union and held increasing roles of responsibility at Goldman Sachs and Dupont Merck prior in his career.
Thomas Hess is an experienced financial expert. From August 2014 until June 2021, Mr. Hess served as Chief Financial Officer and Senior Vice President of Finance of Genomind, Inc., a mental health company that developed and sold a pharmacogenomic test that analyzed how an individual’s genes may affect medication outcomes. From September 2011 until its sale in April 2014, Mr. Hess served as Chief Financial Officer and Executive Vice President of Finance of The Keane Organization, a comprehensive provider of unclaimed property services. Mr. Hess also previously served in various other capacities including, but not limited to, Chief Financial Officer and Senior Vice President of Yaupon Therapeutics, Inc.; Chief Financial Officer and Vice President, Finance of Adolor Corporation; Corporate Controller of Vicuron Pharmaceuticals, Inc.; and Senior Manager – Accounting and Audit of KPMG. Mr. Hess was formerly an adjunct faculty member/lecturer at Pennsylvania State University and DeSales University. Mr. Hess received his B.S. in accounting from The Pennsylvania State University and his MBA from Katz Graduate School of Business, University of Pittsburgh. Mr. Hess is a Certified Public Accountant in the state of Pennsylvania. He currently serves on the Alumni Council of Penn State and is the Chairman of the Nittany Lion Club Annual Fund.
Ron is a US trained board certified medical oncologist having worked in the biopharmaceutical industry since 1999. Over his career, Ron has worked in all areas of clinical development including phase 1, 2 and 3 clinical trials. He has drug development experience in both solid and hematological malignancies and has interacted extensively with FDA, EMEA, Canadian and Japanese health authorities. In his most recent role at Exelixis, he oversaw cabozantinib’s (XL184) development in prostate cancer with two ongoing phase 3 registrational studies underway. Over the years, Ron has managed both large and small groups and very much enjoys mentoring colleagues.
Dr. Rosenblatt is a subject matter expert in the chemistry and manufacturing controls (CMC) of bio-therapeutics, with a proven 30-plus year track record in biotechnology and the pharmaceutical industry. He developed, transferred, and validated purification processes for multiple new molecular entities through all stages of drug development, including licensure by the application of an innovative and comprehensive approach. He is experienced in regulatory and technical support for non-traditional biologics and combined medical/biological devices. Dr. Rosenblatt was responsible for a pharmaceutical development group at Centocor/Johnson & Johnson that developed processes that led to the commercial approval of two biologic candidates, Stelara® and Simponi®.
Dr. Niecestro is the Managing Director of AccelaPHARM, LLC, an executive regulatory-development strategy company in the biotechnology and pharmaceutical industries. Dr. Niecestro was a founder and served as the Vice President of Clinical and Regulatory Affairs for Axsome Therapeutics as well as was a founder and served as the Executive Vice President of Clinical and Regulatory Affairs for TG Therapeutics and Keryx Biopharmaceuticals. Dr. Niecestro held numerous senior management positions in the pharmaceutical industry serving as the Vice President of Clinical Development for Andrx Laboratories; Senior Director, Clinical Development and Therapeutic Head for Gastrointestinal, Oncology and Stroke at Eisai Inc.; and Director, Clinical Operations and NDA Planning for Organon Inc. Dr. Niecestro has been involved in the filing of over 60 INDs; approval of 13 NDAs or BLAs in the United States; has over 60 peer-reviewed scientific presentations, abstracts and/or publications, and holds 3 patents. Dr. Niecestro completed his graduate and post-graduate work at the University of Illinois at Chicago.
Dr. Korczak is a translational science executive with established track record of developing drugs from discovery through IND and into clinical Proof of Concept (POC) studies. She has an excellent knowledge of drug discovery, pharmacology, pharmacokinetics (PK), toxicology, manufacturing of drug substance/product, early clinical development and regulatory requirements. Her leadership in start-up and early stage biotechnology companies resulted in accelerated drug development across multiple therapeutic areas including oncology, dermatology, inflammatory diseases, cardiology, and infectious diseases.
Scientific Advisory Board Members
Dr. Wong is the Chief of Hematology and Medical Oncology at The Perlmutter Cancer Center at NYU Langone Medical Center. During his distinguished career, Dr. Wong served in various investigative and leadership roles at Dana-Farber Cancer Institute, Brigham & Women’s Hospital, and Harvard Medical School. His work has been published in over 250 scientific publications, and his world-renowned research has provided new insight into genetic and environmental causes of lung cancer, enabling novel lung cancer therapies. Currently, Dr. Wong continues his investigative pursuits, in to developing novel therapeutic strategies for small cell and non-small cell lung cancer. He received both his PhD and MD from Columbia University, completed his residency at Massachusetts General Hospital, and was a fellow at the Dana-Farber Cancer Institute.
Dr. Richardson is Corman professor of Medicine at Harvard medical School and serves as Clinical Program Leader and Director of Clinical Research of the Jerome Lipper Multiple Myeloma Center and has led several novel, biologically-derived translational efforts in multiple myeloma. He holds numerous advisory board positions and is a member of dozens of professional organizations. In addition, he has published hundreds of original papers, reviews, chapters, and monographs in many leading peer-reviewed publications including The New England Journal of Medicine, Blood, and Journal of Clinical Oncology and many others. Dr. Richardson has led the study and clinical development of numerous novel drugs in the treatment of multiple myeloma which have contributed to improvement in outcome for patients.
Dr. Eder is the Clinical Director of the Early Drug Development Program, performing Phase I clinical trials of new cancer medicines. He was previously the Clinical Director of the Experimental Therapeutics Program for the Dana-Farber/Harvard Cancer Center and had responsibility for the trials performed at the DF/HCC. These clinical and basic research activities have involved collaboration with clinical and basic scientists at Harvard and elsewhere, the Cancer Therapy Evaluation Program of the National Cancer Institute, presentations at national and international meetings, and correspondence with a number of leaders in the field of cancer drug development.
Dr. Dixon obtained a Ph.D. in molecular genetics from the University of Toronto and is currently an Associate Professor in the Department of Biology at Stanford University. Dr. Dixon is a pioneer in the investigation of non-apoptotic cancer cell death, having spearheaded the discovery of ferroptosis and related iron-dependent cell death mechanisms. His laboratory is focused on detailed characterization of small molecule mechanism of action in cancer, with a view to discovering novel treatments for various indications.
Dr. Rayner received his Ph.D. in Microbiology at Colorado State University (CSU) in 1998 as part of the Arthropod-borne and Infectious Diseases Laboratory where he studied the factors influencing vector-competence for yellow fever virus and dengue viruses (DENV). He then completed two post-doctoral research programs with the American Society for Microbiology/National Centers for Infectious Diseases at the Centers for Disease Control and Prevention (CDC), Division of Arthropod-borne Infectious Diseases and the National Research Council at the United States Army Medical Research Institute of Infectious Diseases. Dr. Rayner continued his research in the private sector before joining academia at University of South Alabama and becoming the director of the Laboratory of Infectious Diseases (LID). Since the beginning of the COVID-19 pandemic, Dr. Rayner and colleagues have been studying SARS-CoV-2 virus, including isolation and characterization of genetic variants from patients both in tissue culture cells and in hamsters, evaluation of disinfectants, and antiviral drug discovery and development. In establishing the hamster model of SARS-CoV-2 virus infection, interesting gender differences were observed, and gender as a biological variable in virus infections continues to be of significant interest in Dr. Rayner’s future research plans.